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Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
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La sperimentazione clinica NCT05867433 è uno studio interventistico per Malattie cardiovascolari, Nutrizione, Attività fisica, attualmente in arruolamento. Avviato il 27 settembre 2023, prevede di arruolare 500 partecipanti. Sotto la guida di Texas A&M University, dovrebbe concludersi entro il 15 aprile 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 12 settembre 2025.
Sommario breve
Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.
Descrizione dettagliata
The investigators will conduct a cluster-randomized controlled trial to evaluate the impact of the Strong Teens for Healthy Schools (STHS) program on cardiovascular disease-related outcomes. STHS is a multi-level, theory-based civic engagement program to catalyze positive food and physical activity environmental change and improve cardiovascular disease-related health (CVD) outcomes among 6th and 7th-grade students.
Title 1 middle schools in Texas (n=20) with > 40% Hispanic and Black students will be randomized at baseline to the intervention condition (STHS program) or control condition (will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming) (n=20-25 students per school).
The investigators hypothesize that students who participate in STHS will have reduced MetS risk, improved positive youth developmental outcomes, and improved social and environmental outcomes immediately post-intervention and one year after study completion compared to students in a control condition.
Titolo ufficiale
Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments
Condizioni
Malattie cardiovascolariNutrizioneAttività fisicaPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- IRB2022-1159D
- R01MD018214 (Sovvenzione/Contratto NIH (USA))
Numero NCT
Data di inizio (effettiva)
2023-09-27
Ultimo aggiornamento pubblicato
2025-09-12
Data di completamento (stimata)
2027-04-15
Arruolamento (previsto)
500
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleSTHS Intervention Participants in this group (10 schools) will participate in the STHS program. | STHS Intervention STHS program
The intervention group (10 schools) will participate in the STHS program. During the fall semester (September to December), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that provide education on civic engagement, healthy eating, and physical activity. During the spring semester (February to May), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that focus on implementing the school health environmental change project and receive support for maintaining individual-level healthy eating and physical activity behaviors. |
AltroUsual Care Participants in this group (10 schools) will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming. | Cura abituale No STHS program
The usual care group will be offered the same activities as the intervention group after the conclusion of the research study. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Presence or absence of metabolic syndrome (MetS) | MetS is present after identifying abdominal obesity plus at least two of the four other MetS Risk factors: high blood pressure, high blood sugar, low HDL cholesterol, and high triglyceride levels.
MetS = (abdominal obesity) + (2 of 4 other MetS Risk factors)
Measures to determine MetS risk factors:
1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age
2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L
5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Change in the number of MetS risk factors | Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors)
Measures to determine MetS risk factors:
1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age
2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg)
3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes
4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L
5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Positive Youth Development score | Positive youth development will be measured using a 5 C's Model of Positive Youth Development Scale-Short Form (PYD-SF): A 34-item scale that assesses the strength of psychological, behavioral, and social development in youth.
The five dimensions measured are:
1. Competence (sense of proficiency)
2. Confidence (self-worth, self-efficacy)
3. Character (adherence to societal and cultural rules)
4. Connection (bonds with people and institutions)
5. Caring (sympathy and empathy towards others) | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Blood pressure level | Blood pressure (systolic and diastolic) will be measured with two numbers using an automated Omron sphygmomanometer. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Concentration of blood glucose | Glucose will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Waist circumference | Waist circumference will be measured at the midpoint between the floating rib and iliac crest using a tape measure. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Concentration of HDL cholesterol | HDL-C will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Concentration of serum triglycerides | Triglycerides will be measured using a portable Cholestech LDX analyzer to assess a single capillary blood sample following an overnight fast. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Height | Height will be measured using a stadiometer in inches. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Weight | Weight will be measured with a scale in pounds. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Body mass index (BMI) | Weight will be measured with a scale, and height will be measured using a stadiometer. BMI will be calculated as BMI = (weight (lb)/height (inches)2) x 703. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Concentration of subdermal carotenoids | The concentration of subdermal carotenoids will assess the changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
Accelerometer-derived physical activity estimation | Physical activity will be measured using Actigraph accelerometers. Measurements will include light physical activity (PA), moderate PA, moderate to vigorous PA, and vigorous PA. | Baseline to 9 months |
Sedentary time | Sedentary time will be measured using Actigraph accelerometers. | Baseline to 9 months |
Time spent sleeping | Sleep time will be measured using Actigraph accelerometers. | Baseline to 9 months |
Physical fitness capacity estimation | Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness. | Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention |
School physical activity and nutrition environment assessment | The school's physical activity and nutrition environments will be measured using a self-reported School Environment Survey. | Baseline to 9 months |
Assessment of perceptions of school environments and school-specific dietary intake patterns | Perceptions related to physical activity and nutrition within the school setting will be measured using the Perceptions of the Environment and Patterns of Diet at School (PEA-PODS) survey. | Baseline to 9 months |
Assessment of perceived sociopolitical control | Perceived sociopolitical control will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' perceived sociopolitical control (i.e., participation in advocacy programs and optimism for change). | Baseline to 9 months |
Assessment of assertiveness | Assertiveness will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' assertiveness (i.e., ability to engage with adults and peers). | Baseline to 9 months |
Assessment of participatory competence and decision-making | Participatory competence and decision-making will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' participatory competence and decision-making (i.e., ability to influence group decision-making). | Baseline to 9 months |
Assessment of advocacy outcome efficacy | Advocacy outcome efficacy will be measured using the Youth Engagement and Action for Health (YEAH!) survey. The YEAH survey will be used to assess students' advocacy outcome efficacy (i.e., belief in their ability to work with others to improve the school's physical activity and nutrition environment). | Baseline to 9 months |
Peer concentration of subdermal carotenoids | The concentration of subdermal carotenoids will assess peers' engagement in health behaviors changes in fruit and vegetable consumption using the Veggie Meter: A non-invasive, portable machine that measures subdermal carotenoid levels using resonance Raman spectroscopy. | Baseline to 9 months |
Peer Body mass index (BMI) | Peers' engagement in health behaviors will be measured by the change in peers' BMI. Weight will be measured with a scale, and height will be measured using a stadiometer. Calculate BMI with the formula: BMI = (weight (lb)/height (inches)2) x 703. | Baseline to 9 months |
Peer physical fitness capacity estimation | Peers' engagement in health behaviors will be measured by the change in peers' physical fitness. Physical fitness will be measured using the FitnessGram PACER multistage aerobic capacity test: Children will run back and forth 20 meters, with an initial running speed of 8.5 km/hour and a progressive 0.5-km/hour increase in running speed every minute. As the test continues it becomes progressively harder. The number of laps completed is used to estimate children's physical fitness physical fitness. | Baseline to 9 months |
Criteri di eleggibilità
Età idonea
Bambino, Adulto, Adulto anziano
Età minima
8 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
- > 50 6th and 7th grade students
- > 40% economically disadvantaged students
- > 40% Black and Hispanic students
Student Inclusion Criteria:
- 6th or 7th grade student
- Attend a Title 1 middle school that is participating in the STHS intervention
- Read and understand English
Student Exclusion Criteria:
- Participation in a weight loss program in the past 3 months
- Presence of a condition that prevents participation in physical activity
Texas A&M UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Contatti principali dello studio
Contatto: Jacob S Szeszulski, PhD, 972-231-5362, [email protected]
Contatto: Alexandra L MacMillan Uribe, PhD, 972-952-9275, [email protected]
1 Centri dello studio in 1 paesi
Texas
Texas A&M AgriLife Dallas Center, Dallas, Texas, 75252, United States
Jacob Szeszulski, PhD, Contatto, 972-231-5362, [email protected]
Alexander MacMillan Uribe, PhD, Contatto, 972-952-9275, [email protected]
In arruolamento